Ayala Pharmaceuticals announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to AL102, a Gamma Secretase Inhibitor, for the treatment of desmoid tumors. AL102 is an investigational small molecule GSI, currently being evaluated in the Phase 3 RINGSIDE study in DT. Orphan drug designation is granted by the FDA to drugs and biologics intended for treatment, prevention or diagnosis of a rare disease or condition that affects fewer than 200,000 people in the U.S. at the time of designation.
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